Status:
COMPLETED
OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
Lead Sponsor:
Olympus Biotech Corporation
Conditions:
Tibial Nonunions
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.
Detailed Description
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Devi...
Eligibility Criteria
Inclusion
- Patients must show radiographic skeletal maturity
- Documented evidence of previous fracture management
- Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation
- Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment
Exclusion
- Patients who do not have adequate vascularity to permit healing
- Patients with inadequate skin coverage
- Patients with chronic use of steroidal medications
- Patients with active infection systemically or at the site of nonunion.
Key Trial Info
Start Date :
February 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1999
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00679328
Start Date
February 1 1992
End Date
December 1 1999
Last Update
June 10 2011
Active Locations (18)
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1
Mesa, Arizona, United States
2
Modesto, California, United States
3
San Diego, California, United States
4
Stanford, California, United States